Everyone that participates in the Life Sciences industry that uses software anywhere in their processes has wrestled with the challenges of Software Validation. Companies spend a considerable amount of time, money, energy and expertise in ensuring that they address all of the requirements necessary as defined in in 21 CFR Part 11 to make sure that the software is going to both satisfy the FDA Regulatory Requirements and meet business expectations. The most challenging validation portion seems to uniformly be Process Qualification (PQ). The time and effort to determine and address where the software capability ends and the human process interaction begins can be very challenging. It is easy to miss some of the important supporting elements that are absolutely required and necessary to make Process Qualification successful. If we were to quantify those requirements at a very high level it would boil down to:
Documentation providing directions, limits and expectations for users: Work Instructions, Standard Operating Procedures.
Consideration of tooling and hardware necessary to complete the processes supported by the software. Example: Label Printers driven by print software.
Training of users, not just on the use of the software but on the parameters and criteria for the whole of the process the software supports.
Implementation of metrics that monitor and report on the impact of the software and the effectiveness of the processes it supports. Has it improved, compromised or had negligible impact on the process?
Once all of that time and energy has been invested in the Validation Process it is unfortunate that many organizations fall short of gaining the full benefit of what PQ can offer. If any of the bulleted items above is not properly addressed, the risk is unnecessarily increased and post-validation process issues could occur.
Many organizations already use some form of Risk Assessment as part of their engineering and analysis processes. Breaking down the process into steps identifying them as software, hardware or human interaction and then performing even a simple Risk Assessment against each one, can greatly help identify and quantify the elements that pose the greatest post-validation risk if not addressed. Using even a simple RPN calculation: (Likelihood of Occurrence x Likelihood of Detection x Severity) will quickly highlight areas of risk in any portion of the process. These areas of risk can then be mitigated by some combination of the elements we identified earlier such as Documentation and Training. Additionally, Risk Analysis can be repeated over time to access the effectiveness of the process and assure that the right controls are in place or if they require some adjustment or modification for optimal effectiveness.
Broadening your vision and mindset to look at the validation process as a potential improvement tool and value added activity can reap benefits that you may not have realized were possible.